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Trial registered on ANZCTR


Registration number
ACTRN12621000702819p
Ethics application status
Submitted, not yet approved
Date submitted
9/04/2021
Date registered
8/06/2021
Date last updated
8/06/2021
Date data sharing statement initially provided
8/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating Healthy Immunity in Children at Childcare Using Probiotics (HICCUP) Study
Scientific title
Investigating the effect of probiotics on the incidence of cold and flu symptoms in children at childcare: A randomised, double blind, placebo controlled trial
Secondary ID [1] 303908 0
None
Universal Trial Number (UTN)
Trial acronym
HICCUP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired immunity 321492 0
Cold 321493 0
Flu 321876 0
Condition category
Condition code
Public Health 319247 319247 0 0
Other public health
Respiratory 319602 319602 0 0
Other respiratory disorders / diseases
Infection 319603 319603 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants who are randomly assigned to the intervention group will receive capsules containing the probiotic Bifidobacterium animalis HN019 (6X109 colony forming units).

Since the participants are children aged 1-5 years, the tablets are recommended to be broken open and the powder sprinkled into food or drinks.

Participants will be instructed to take one capsule a day for a period of 10 weeks.

Adherence will be assessed by asking participants to enter the number of remaining capsules they have in the bottle at the post-intervention data collection phase
Intervention code [1] 320215 0
Prevention
Comparator / control treatment
Approximately half the participants will be assigned to receive placebo capsules containing corn-derived maltodextrin. These capsules will be identical in taste, smell and appearance to the intervention capsules.

Since the participants are children aged 1-5 years, the tablets are recommended to be broken open and the powder sprinkled into food or drinks.

Participants will be instructed to take one capsule per day for 10 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 327120 0
The average number of days with cold and flu like symptoms per week is the primary outcome measure for this study.

Each week for the 10 weeks of the study, we will send parents a text or email asking how many days in the previous week their child has had symptoms of a cold or flu such as a runny nose. Parents will be asked to send back a reply with the number of days (between 0 and 7).
Timepoint [1] 327120 0
Daily symptoms will be assessed for 10 weeks post-intervention commencement.
Secondary outcome [1] 393864 0
There is no secondary outcome measure
Timepoint [1] 393864 0
Nil

Eligibility
Key inclusion criteria
Children will be eligible to participate in the study if they
• Are aged between 12 months and less than 5 years at the time of enrolment
• Attend childcare regularly 2 sessions/week or more
• Have not had antibiotics in the last two weeks
• Do not have a sibling enrolled in the study
• Are not on immune suppressant therapy
Minimum age
12 Months
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

The randomisation schedule will be arranged and held by Fonterra Cooperative New Zealand who are supplying the capsules for this study. Fonterra will provide capsules in numbered bottles and hold the randomisation schedule at their site (different from the the research site) throughout the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created
by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
None
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 144 children attending for 2 sessions/week for the 10-week study period allows for a 90% chance of detecting a reduction of days with symptoms from 4% in the control group to 2% in the treatment group at the 2.5% level of significance. Allowance for 20% attrition has been made. An intention-to-treat analysis will be conducted in SAS 9.4 using generalised linear regression to analyse the average number of symptom days per week over the study period between the probiotic and placebo groups.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/06/2021
Actual
Date of last participant enrolment
Anticipated
9/08/2021
Actual
Date of last data collection
Anticipated
18/10/2021
Actual
Sample size
Target
144
Accrual to date
Final
Recruitment outside Australia
Country [1] 23585 0
New Zealand
State/province [1] 23585 0

Funding & Sponsors
Funding source category [1] 308296 0
Commercial sector/Industry
Name [1] 308296 0
Fonterra Co-operative Ltd.
Country [1] 308296 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Department of Psychological Medicine
University of Auckland
22-30 Park Avenue
Grafton
Auckland 1023
New Zealand
Country
New Zealand
Secondary sponsor category [1] 309102 0
None
Name [1] 309102 0
Address [1] 309102 0
Country [1] 309102 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308270 0
Central Health and Disability Ethics Committees
Ethics committee address [1] 308270 0
Health and Disability Ethics Committee Ministry of Health Health and Disability Ethics Committees PO Box 5013 Wellington 6140
Ethics committee country [1] 308270 0
New Zealand
Date submitted for ethics approval [1] 308270 0
06/04/2021
Approval date [1] 308270 0
Ethics approval number [1] 308270 0

Summary
Brief summary
Respiratory tract infections in children under the age of 5 years are common and are a major cause of hospitalisation and even death. More minor respiratory tract infections such as colds and flus often result in children being unable to attend childcare due to the illness, and their parents therefore being unable to attend work in order to care for them. The bacteria that reside in the human gut play an important role in immunity. However, when the gut bacteria are out of natural balance, health and immunity can be compromised. Probiotic supplementation is one way in which the composition of the gut microbiota can be restored. Probiotics are live micro-organisms that have been shown to reduce the incidence, duration, and severity of viral and cold and flu like illnesses in children. This study will conduct a randomised, double-blind, placebo controlled trial to test whether a probiotic can reduce the number of days children have symptoms of cold and flu-like illnesses.
Trial website
Trial related presentations / publications
Public notes
None

Contacts
Principal investigator
Name 110142 0
Dr Rebecca Slykerman
Address 110142 0
Department of Psychological Medicine
Room 3033, Building 507
University of Auckland
22-30 Park Avenue
Grafton
Auckland 1023
New Zealand
Country 110142 0
New Zealand
Phone 110142 0
+6499231132
Fax 110142 0
Email 110142 0
[email protected]
Contact person for public queries
Name 110143 0
Rebecca Slykerman
Address 110143 0
Department of Psychological Medicine
Room 3033, Building 507
University of Auckland
22-30 Park Avenue
Grafton
Auckland 1023
New Zealand
Country 110143 0
New Zealand
Phone 110143 0
+6499231132
Fax 110143 0
Email 110143 0
[email protected]
Contact person for scientific queries
Name 110144 0
Rebecca Slykerman
Address 110144 0
Department of Psychological Medicine
Room 3033, Building 507
University of Auckland
22-30 Park Avenue
Grafton
Auckland 1023
New Zealand
Country 110144 0
New Zealand
Phone 110144 0
+6499231132
Fax 110144 0
Email 110144 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
In line with ethical guidelines only the research team will have access to individual level participant data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11305Study protocol  [email protected] 381771-(Uploaded-08-04-2021-12-04-28)-Study-related document.docx



Results publications and other study-related documents

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